Momenta Resumes Patient Enrollment in the Necuparanib (MOM-M402-103) Phase 2 Study
22 December 2015 - 12:00AM
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today announced that it
has resumed patient enrollment in its ongoing Phase 2 portion of
the trial “A Phase I/II, Two-Part, Multicenter Study to Evaluate
the Safety and Efficacy of M402 in Combination with nab-Paclitaxel
and Gemcitabine in Patients with Metastatic Pancreatic Cancer.”
Study enrollment was paused last month following Momenta’s
acceptance of recommendations from its Data Safety Monitoring Board
(DSMB) to develop guidelines for diagnosing and managing
thrombocytopenia, based on a limited number of specific toxicities
observed in the study.
“We are pleased that following their review of
the protocol amendment, the DSMB is supportive of resuming patient
enrollment in our necuparanib study,” said Jim Roach, M.D., Senior
Vice President of Development and Chief Medical Officer of Momenta
Pharmaceuticals. “Given the projected timelines to obtain
Institutional Review Board approval of the protocol amendment
across study sites, we now anticipate that the top-line data should
be available in the second half of 2017.”
About NecuparanibNecuparanib
(M402) is a novel oncology drug candidate engineered to have a
broad range of effects on tumor cells. The use of heparins to treat
venous thrombosis in cancer patients has generated numerous reports
of antitumor activity; however, the dose of these products has been
limited by their anticoagulant activity. Leveraging its experience
in deciphering the structure-function relationships of complex
therapeutics, Momenta engineered necuparanib from unfractionated
heparin to have significantly reduced anticoagulant activity while
preserving relevant antitumor properties associated with heparins.
A Phase 2 randomized, double-blind, controlled study to evaluate
the antitumor activity of necuparanib in combination with
nab-paclitaxel (Abraxane®) plus gemcitabine, versus nab-paclitaxel
plus gemcitabine alone in pancreatic cancer is currently underway.
Necuparanib has received Orphan Drug and Fast Track designations
from the U.S. Food and Drug Administration (FDA) for the treatment
of pancreatic cancer.
About MomentaMomenta
Pharmaceuticals is a biotechnology company specializing in the
detailed structural analysis of complex drugs and is headquartered
in Cambridge, MA. Momenta is applying its technology to
the development of generic versions of complex drugs, biosimilar
and potentially interchangeable biologics, and to the discovery and
development of novel therapeutics for oncology and autoimmune
indications.
To receive additional information about Momenta,
please visit the website at www.momentapharma.com, which does
not form a part of this press release.
Our logo, trademarks, and service marks are the
property of Momenta Pharmaceuticals, Inc. All other trade names,
trademarks, or service marks are property of their respective
owners.
Forward Looking
StatementsStatements in this press release regarding
management's future expectations, beliefs, intentions, goals,
strategies, plans or prospects, are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995, including but not limited to statements about the
Company's future conduct of its necuparanib study; the timing of
regulatory submissions and enrollment following the current
enrollment pause; the availability and announcement of clinical
data; and the review of the necuparanib study plans by the U.S.
Food and Drug Administration. Forward-looking statements may
be identified by words such as "anticipate," "believe," "continue,"
"could," "hope," "target," "project," "goal," "objective,"
"guidance," "plan," "potential," "predict," "might," "estimate,"
"expect," "intend," "may," "seek,” "should," "will," "would," "look
forward" and other similar words or expressions, or the negative of
these words or similar words or expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors, including those referred to under the section "Risk
Factors" in the Company's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2015, filed with the Securities and
Exchange Commission, as well as other documents that may be filed
by the Company from time to time with the Securities and Exchange
Commission. As a result of such risks, uncertainties and factors,
the Company's actual results may differ materially from any future
results, performance or achievements discussed in or implied by the
forward-looking statements contained herein. The Company is
providing the information in this press release as of this date and
assumes no obligations to update the information included in this
press release or revise any forward-looking statements, whether as
a result of new information, future events or otherwise.
Investor Relations:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
Media Relations:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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